Radiation Induced Cardiac DamageCARDNCT02481778
Monitoring Radiation Induced Cardiac Damage by Blood Markers
An observational study of Radiation Induced Cardiac Damage, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Rationale: Radiation induced cardiac toxicity after treatment for intrathoracic tumours is a clinically relevant problem. So far, no clinical prediction models exist for cardiac toxicity. In particular, the relationship between radiation dose parameters and the risk of cardiac toxicity remains to be determined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Induced Cardiac Damage
- What is being tested?
- Blood sampling
- How many people
- 96 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Sep 2015to Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with esophageal- or non small cell lung cancer treated with radiotherapy with curative intention, with or without chemotherapy, with or without surgery, at the department of radiotherapy at the University Medical Centre Groningen
Who may be able to join
- Histologically proven oesophageal- or lung cancer (adeno-, or squamous cell carcinoma or other NSCLC type)
- Older than 18 years
- Written informed consent
Who cannot join
- Prior radiotherapy to the chest including radiotherapy for breast cancer
- Patients treated with palliative intent
Trial locations and contacts
1 site in 1 country.
About this study
Rationale:
Radiation induced cardiac toxicity after treatment for intrathoracic tumours is a clinically relevant problem. So far, no clinical prediction models exist for cardiac toxicity. In particular, the relationship between radiation dose parameters and the risk of cardiac toxicity remains to be determined.
Clinical prediction models for cardiac toxicity are difficult to obtain, e.g. due to long latency time. Therefore, objective surrogate markers, for cardiac toxicity such as NT pro BNP and hs-TNT, as obtained during and after treatment may be of great value.
Objective:
The main objective to find a correlation between the rise in NT pro BNP level and the radiation dose given to the heart.
- Conditions
- Radiation Induced Cardiac Damage
- Being tested
- Blood sampling
- Keywords
- Radiotherapy, Cardiac, Toxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percentage of rise of the level of NT pro BNP after radiotherapy
Measured: At 1 year after end of radiation therapy
Secondary outcomes (2)
Cardiac events
A new diagnosis of: heart failure, myocardial infarction or a newly diagnosed rhythm disorder will be scored as a cardiac event. Myocardial ischaemia requiring intervention and changes in cardiac medication in case of deterioration of known heart failure will be analysed by a cardiologist to decide whether or not to score this as an event. Events will be scored according the CTCAE 4.2 criteria.
Measured: After start treatment up to 2 years after end of radiation therapy.
Change in percentage of rise of hs-TNT during or after treatment
Measured: At day 1 start radiation therapy and at last day of radiation therapy (an expected average of 5 weeks after start of radiation therapy) and at 4 weeks, 6 months, 1 and 2 years after end of radiation therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study start8 Sep 2015
- Primary completionAug 2020
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radiation Induced Cardiac DamageStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481778
- Sponsor's protocol ID
- RT2014-01
- Acronym
- CARD
- Status last verified
- Feb 2024
- First submitted
- 11 May 2015
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Beukema JC, Haveman JW, Langendijk JA, Oldehinkel E, van den Bergh ACM, de Haan JJ, van Melle JP, van Luijk P, Muijs CT. Blood biomarkers for cardiac damage during and after radiotherapy for esophageal cancer: A prospective cohort study. Radiother Oncol. 2024 Nov;200:110479. doi: 10.1016/j.radonc.2024.110479. Epub 2024 Aug 18.
PubMed 39154840
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Radiation Induced Cardiac Damage by Blood Markers
- ClinicalTrials.gov ID
- NCT02481778
- Acronym / sponsor ID
- CARD / RT2014-01
- Conditions
- Radiation Induced Cardiac Damage
- Keywords
- Radiotherapy, Cardiac, Toxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 8 Sep 2015 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale:
Radiation induced cardiac toxicity after treatment for intrathoracic tumours is a clinically relevant problem. So far, no clinical prediction models exist for cardiac toxicity. In particular, the relationship between radiation dose parameters and the risk of cardiac toxicity remains to be determined.
Clinical prediction models for cardiac toxicity are difficult to obtain, e.g. due to long latency time. Therefore, objective surrogate markers, for cardiac toxicity such as NT pro BNP and hs-TNT, as obtained during and after treatment may be of great value.
Objective:
The main objective to find a correlation between the rise in NT pro BNP level and the radiation dose given to the heart.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with esophageal- or non small cell lung cancer treated with radiotherapy with curative intention, with or without chemotherapy, with or without surgery, at the department of radiotherapy at the University Medical Centre Groningen
Key inclusion criteria (3 listed)
- Histologically proven oesophageal- or lung cancer (adeno-, or squamous cell carcinoma or other NSCLC type)
- Older than 18 years
- Written informed consent
Key exclusion criteria (2 listed)
- Prior radiotherapy to the chest including radiotherapy for breast cancer
- Patients treated with palliative intent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling | Other | – |
Primary outcome
Change in percentage of rise of the level of NT pro BNP after radiotherapy
Time frame: At 1 year after end of radiation therapy
2 secondary outcomes
Cardiac events
Time frame: After start treatment up to 2 years after end of radiation therapy.
Change in percentage of rise of hs-TNT during or after treatment
Time frame: At day 1 start radiation therapy and at last day of radiation therapy (an expected average of 5 weeks after start of radiation therapy) and at 4 weeks, 6 months, 1 and 2 years after end of radiation therapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Derived from this study: PubMed 39154840Beukema JC, Haveman JW, Langendijk JA, Oldehinkel E, van den Bergh ACM, de Haan JJ, van Melle JP, van Luijk P, Muijs CT. Blood biomarkers for cardiac damage during and after radiotherapy for esophageal cancer: A prospective cohort study. Radiother Oncol. 2024 Nov;200:110479. doi: 10.1016/j.radonc.2024.110479. Epub 2024 Aug 18.
Related trials for Radiation Induced Cardiac Damage
RecruitingObservational study
Health Effects of CArdiac FluoRoscopy and MOderN RadIotherapy in PediatriCs - Radiotherapy
Neoplasms
Recruiting
Early Identification of Cardivascular Damage Induced by Chemotherapy and Antineoplastic Treatments in Pediatric Age
Cardiotoxicity
Active, not recruiting
Dosimetric Comparison of Target Volume, Heart and Left Lung in Post Mastectomy Radiotherapy (RT) of Left Sided Breast Cancer by Free Breathing (FB) Versus Deep Inspiration Breath Hold (DIBH) Technique
Carcinoma Breast, Radiation Therapy for Primary Breast Cancer
Recruiting
The Potential Protective Effect of Using Muscle Relaxants During Electroporation Ablation (PFA)
Kidney Failure, Acute, Myopathy; Drugs
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation Induced Cardiac Damage, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in percentage of rise of the level of NT pro BNP after radiotherapy (time frame: At 1 year after end of radiation therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02481778, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.